Atopic Dermatitis (AD)Phase 3NCT07185282
A Phase 3 Study of MH004 Ointment in Patients With Mild to Moderate Atopic Dermatitis
A Phase 3 study testing MH004 Ointment in people with Atopic Dermatitis (AD), run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, vehicle-controlled phase III study of MH004 Ointment with a 44-week open-label long-term safety extension period. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and primary efficacy of MH004 Ointment in adolescents and adults with… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- MH004 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2023to 15 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥18 years.
- Clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 1 year prior to Day 1.
- Participants meet all the following atopic dermatitis criteria:
- VC period: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit.
- LTS period: IGA 0 to 4, affected BSA 0% to 20% (excluding scalp) at Week 8.
- Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
- Participants who have at least one AD lesion not located on the hands, feet, or genitalia.
- Willingness to avoid pregnancy or fathering of children. -
Who cannot join
- Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- Concurrent conditions and history of other diseases:
- Immunocompromised.
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
- Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
- Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
Show all 15Show fewer
- Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
- Other types of eczema.
- Clinically significant cardiac disease; new cerebral infarction within 6 months from dosing; malignancies within 5 years from dosing; low hemoglobin; severe renal disease on dialysis; liver disease.
- Systemic corticosteroids treated within 4 weeks before dosing; immunizations or sedating antihistamines treated within 4 weeks before dosing; other topical treatments for AD within 1 week before dosing.
- Previously received Janus kinase (JAK) inhibitors, systemic or topical.
- Ultraviolet light therapy or prolonged exposure to UV radiation within 2 weeks before dosing.
- Liver function tests: AST or ALT ≥ 2 × ULN; alkaline phosphatase and/or bilirubin > 1.5 × ULN.
- Pregnant or lactating participants, or those considering pregnancy.
- Alcohol or drug abuse. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of MH004 Ointment Followed by a 44-week Open-Label Long-Term Safety Extension Period in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
This is a multicenter, randomized, double-blind, vehicle-controlled phase III study of MH004 Ointment with a 44-week open-label long-term safety extension period. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and primary efficacy of MH004 Ointment in adolescents and adults with mild to moderate atopic dermatitis.
Read the detailed description
This phase III trial of MH004 Ointment comprises two periods: a vehicle control period and an open-label long-term safety extension period. Participants will be randomly aligned to the 1.0% MH004 Ointment BID or Vehicle BID arm and treated for up to 8 weeks, followed by a 44-week open-label LTS treatment period with 1.0% MH004 Ointment BID. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with mild to moderate atopic dermatitis (AD).
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- MH004 Ointment, Vehicle Ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MH004 OintmentDrug
MH004 1% ointment applied topically to the affected area as a thin film twice daily.
Vehicle OintmentDrug
Matching vehicle ointment applied topically to the affected area as a thin film twice daily.
| Study group | Role | What they receive |
|---|---|---|
| VC Period: MH004 1.0% Ointment BID | Experimental | Participants received MH004 1.0% Ointment twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Receives: Drug: MH004 Ointment |
| VC Period: Vehicle Ointment BID | Placebo comparator | Participants received vehicle ointment BID from Day 1 to Week 8 during the VC Period. Receives: Drug: Vehicle Ointment |
| LTS Period: MH004 1.0% Ointment BID | Experimental | Participants who applied MH004 1.0% ointment during VC Period, continued applying MH004 1.0% ointment BID from Week 8 to 52 during the LTS Period. Receives: Drug: MH004 Ointment |
| LTS Period: Vehicle Ointment to MH004 1.0% Ointment BID | Placebo comparator | Participants who applied vehicle ointment BID during the VC Period, were randomized to apply MH004 1.0% ointment topically BID from Week 8 to 52 during the LTS Period. Receives: Drug: Vehicle Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving Investigator's Global Assessment treatment success (IGA-TS) at Week 4.
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
Measured: Baseline to week 4.
Proportion of participants achieving EASI-75 at Week 4.
EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
Measured: Baseline to week 4.
Secondary outcomes (9)
Key Secondary Endpoints: Proportion of participants achieving IGA-TS at Week 8.
The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
Measured: Baseline to week 8.
Key Secondary Endpoints: Proportion of participants achieving EASI-75 at Week 8.
An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
Measured: Baseline to week 8.
Key Secondary Endpoints: Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (INRS) from baseline to Week 4.
The Itch NRS is a daily patient-reported measure (24-hour recall) of the worst level of itch intensity. Participants will be asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.
Measured: From pre-dose to 4 weeks after the first dose.
Key Secondary Endpoints: Proportion of participants with a clinically meaningful (≥ 6-point) improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form-Sleep Disturbance (8b - 24-hour recall) score at Week 4
This assessment is self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS Short Form - Sleep-Related Impairment (8a) collected in the evening before sleeping; PROMIS Short Form - Sleep Disturbance (8b) collected in the morning after the participant wakes up.
Measured: From pre-dose to 4 weeks after the first dose.
Key Secondary Endpoints: Proportion of participants with a clinically meaningful (≥ 6-point) improvement in the PROMIS Short Form - Sleep - Related Impairment (8a - 24-hour recall) score at Week 4.
This assessment is self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS Short Form - Sleep-Related Impairment (8a) collected in the evening before sleeping; PROMIS Short Form - Sleep Disturbance (8b) collected in the morning after the participant wakes up.
Measured: From pre-dose to 4 weeks after the first dose.
Incidence, Frequency, Duration and Severity of Treatment-Emergent Adverse Event (TEAE)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Measured: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52)
Incidence of Treatment-Emergent Serious Adverse Event (SAE) and Incidence of AEs resulting discontinue medication
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Measured: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52)
Characterization of Pharmacokinetics (Ctrough) of MH004 Ointment in Participants With Mild to Moderate Atopic Dermatitis at Week 2.4.8 during the VC period and Week 12, 24, 36, 52 during the LTS period.
Trough drug concentration (Ctrough)
Measured: Baseline, Week 2, 4, 8, 12, 24, 36, 52
Change From Baseline in DLQI/CDLQI at Week 2, 4, 8, 12, 24, 52
The DLQI/CDLQI (Dermatology Life Quality Index/Children Dermatology Life Quality Index) is a standardized tool for assessing the impact of skin diseases on patients' quality of life. It consists of 10 questions covering multiple dimensions such as symptom perception, daily activities, and social psychology. The total score ranges from 0 to 30, with a higher score indicating a more severe impact of the disease on life.
Measured: Baseline, Week 2, 4, 8, 12, 24, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start10 Jun 2023
- Primary completion13 Dec 2024
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by Minghui Pharmaceutical (Hangzhou) LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185282
- Sponsor's protocol ID
- MH004-P-302
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of MH004 Ointment Followed by a 44-week Open-Label Long-Term Safety Extension Period in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07185282
- Acronym / sponsor ID
- MH004-P-302
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, vehicle-controlled phase III study of MH004 Ointment with a 44-week open-label long-term safety extension period. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and primary efficacy of MH004 Ointment in adolescents and adults with mild to moderate atopic dermatitis.
Detailed description
This phase III trial of MH004 Ointment comprises two periods: a vehicle control period and an open-label long-term safety extension period. Participants will be randomly aligned to the 1.0% MH004 Ointment BID or Vehicle BID arm and treated for up to 8 weeks, followed by a 44-week open-label LTS treatment period with 1.0% MH004 Ointment BID. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with mild to moderate atopic dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VC Period: MH004 1.0% Ointment BID | Experimental | Drug: MH004 OintmentParticipants received MH004 1.0% Ointment twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. |
| VC Period: Vehicle Ointment BID | Placebo comparator | Drug: Vehicle OintmentParticipants received vehicle ointment BID from Day 1 to Week 8 during the VC Period. |
| LTS Period: MH004 1.0% Ointment BID | Experimental | Drug: MH004 OintmentParticipants who applied MH004 1.0% ointment during VC Period, continued applying MH004 1.0% ointment BID from Week 8 to 52 during the LTS Period. |
| LTS Period: Vehicle Ointment to MH004 1.0% Ointment BID | Placebo comparator | Drug: Vehicle OintmentParticipants who applied vehicle ointment BID during the VC Period, were randomized to apply MH004 1.0% ointment topically BID from Week 8 to 52 during the LTS Period. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥18 years.
- Clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 1 year prior to Day 1.
- Participants meet all the following atopic dermatitis criteria:
- VC period: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit.
- LTS period: IGA 0 to 4, affected BSA 0% to 20% (excluding scalp) at Week 8.
Key exclusion criteria (15 listed)
- Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- Concurrent conditions and history of other diseases:
- Clinically significant cardiac disease; new cerebral infarction within 6 months from dosing; malignancies within 5 years from dosing; low hemoglobin; severe renal disease on dialysis; liver disease.
- Systemic corticosteroids treated within 4 weeks before dosing; immunizations or sedating antihistamines treated within 4 weeks before dosing; other topical treatments for AD within 1 week before dosing.
- Previously received Janus kinase (JAK) inhibitors, systemic or topical.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MH004 OintmentMH004 1% ointment applied topically to the affected area as a thin film twice daily. | Drug | LTS Period: MH004 1.0% Ointment BID, VC Period: MH004 1.0% Ointment BID |
| Vehicle OintmentMatching vehicle ointment applied topically to the affected area as a thin film twice daily. | Drug | LTS Period: Vehicle Ointment to MH004 1.0% Ointment BID, VC Period: Vehicle Ointment BID |
Primary outcome
Proportion of participants achieving Investigator's Global Assessment treatment success (IGA-TS) at Week 4.
Time frame: Baseline to week 4.
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
Proportion of participants achieving EASI-75 at Week 4.
Time frame: Baseline to week 4.
EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
9 secondary outcomes
Key Secondary Endpoints: Proportion of participants achieving IGA-TS at Week 8.
Time frame: Baseline to week 8.
Key Secondary Endpoints: Proportion of participants achieving EASI-75 at Week 8.
Time frame: Baseline to week 8.
Key Secondary Endpoints: Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (INRS) from baseline to Week 4.
Time frame: From pre-dose to 4 weeks after the first dose.
Key Secondary Endpoints: Proportion of participants with a clinically meaningful (≥ 6-point) improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form-Sleep Disturbance (8b - 24-hour recall) score at Week 4
Time frame: From pre-dose to 4 weeks after the first dose.
Key Secondary Endpoints: Proportion of participants with a clinically meaningful (≥ 6-point) improvement in the PROMIS Short Form - Sleep - Related Impairment (8a - 24-hour recall) score at Week 4.
Time frame: From pre-dose to 4 weeks after the first dose.
Incidence, Frequency, Duration and Severity of Treatment-Emergent Adverse Event (TEAE)
Time frame: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52)
Incidence of Treatment-Emergent Serious Adverse Event (SAE) and Incidence of AEs resulting discontinue medication
Time frame: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52)
Characterization of Pharmacokinetics (Ctrough) of MH004 Ointment in Participants With Mild to Moderate Atopic Dermatitis at Week 2.4.8 during the VC period and Week 12, 24, 36, 52 during the LTS period.
Time frame: Baseline, Week 2, 4, 8, 12, 24, 36, 52
Change From Baseline in DLQI/CDLQI at Week 2, 4, 8, 12, 24, 52
Time frame: Baseline, Week 2, 4, 8, 12, 24, 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis (AD)
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 1
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MH004 Ointment in people with Atopic Dermatitis (AD), run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving Investigator's Global Assessment treatment success (IGA-TS) at Week 4. (time frame: Baseline to week 4.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.